FDA 510(k) Application Details - K181537

Device Classification Name	System, X-Ray, Angiographic   More FDA Info for this Device
510(K) Number	K181537
Device Name	System, X-Ray, Angiographic
Applicant	Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 Heerbrugg 9435 CH Other 510(k) Applications for this Company
Contact	Georges Hakim Other 510(k) Applications for this Contact
Regulation Number	892.1600   More FDA Info for this Regulation Number
Classification Product Code	IZI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2018
Decision Date	09/07/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review